UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028595
Receipt number R000032731
Scientific Title NBI versus conventional white-light endoscopy with the use of Endocuff for clorectal polyp detection
Date of disclosure of the study information 2017/09/01
Last modified on 2018/08/10 14:28:58

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Basic information

Public title

NBI versus conventional white-light endoscopy with the use of Endocuff for clorectal polyp detection

Acronym

NBI versus conventional white-light endoscopy with the use of Endocuff for clorectal polyp detection

Scientific Title

NBI versus conventional white-light endoscopy with the use of Endocuff for clorectal polyp detection

Scientific Title:Acronym

NBI versus conventional white-light endoscopy with the use of Endocuff for clorectal polyp detection

Region

Japan


Condition

Condition

colorectal polyp

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate colrectal polyp detection rate due to Endocuff-assisted colonoscopy in NBI or WLE

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

colorectal polyp detection rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

NBI colonoscopy with the use of Endocuff

Interventions/Control_2

white light colonoscopy with the use of Endocuff

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients undergoing colonoscopy

Key exclusion criteria

previous bowel resection, inflammatory bowel disease and polyposis syndromes

Target sample size

600


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiki Wada

Organization

Wada Clinic

Division name

Endoscopic department

Zip code


Address

1-4-21, Oda, Wakayama

TEL

073-473-5252

Email

w-yoshi@mtj.biglobe.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshiki Wada

Organization

Wada Clinic

Division name

Endoscopic department

Zip code


Address

1-4-21, Oda, Wakayama

TEL

073-473-5252

Homepage URL


Email

w-yoshi@mtj.biglobe.ne.jp


Sponsor or person

Institute

Wada Clinic

Institute

Department

Personal name



Funding Source

Organization

Wada Clinic

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 08 Month 09 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 08 Month 09 Day

Last modified on

2018 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032731


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name